The country of origin of dental tips

N343773 November 26, 2024 OT:RR:NC:N3:135 CATEGORY: Origin Will Planert Morris, Manning & Martin, LLP 1333 New Hampshire Avenue, NW, Suite 800Washington, DC 20036 RE:  The country of origin of dental tips Dear Mr. Planert: In your letter dated November 5, 2024, on behalf of Inter-Med, Inc. (d/b/a “Vista Apex”), you requested a country of origin ruling on dental tips.  Additional information was provided by email, dated November 12, November 13, and November 14, 2024. The products under consideration are Voyager Premium Irrigation Tips, MST Visco Tips, Micro-Flo Tips, Flexi-Glide Utility Tips, and NiTi SuperFlex Tips.  When attached to a syringe, these tips serve as delivery tips to deliver dental solutions and materials in the oral cavity.  Each dental tip will consist of three or four parts: all consist of (1) a short tube – first tube (also referred to as "cannula” or “needle” in your letter) made of stainless-steel, (2) a long thin hollow tube made of stainless-steel, nickel and titanium (“NiTi”), or polymer tube – second tube/cannula, (3) a plastic hub adapter (“hub”), and optionally – a silicone stopper.  The first tube is pre-bent at a fixed angle and is adjustable or bendable.  The second tube is adhered to the first tube as an extension to the first tube.  You explain that the first tube/cannula (short tube) is tempered and rigid and more easily maintains its shape when bent (either during production or by the practitioner).  This is the essential element for creating a functioning dental tip that can deliver material intraorally.  The second tube/cannula (long tube) functions much like a nozzle or sprayer attachment on the end of a hose – it is an accessory that provides advantages in particular applications. For the MST Visco Tips, Micro-Flo Tips, and Flexi-Glide Tips, the second tube/cannula is a polymer-based tube/cannula.  For the NiTi SuperFlex Tips, the second tube/cannula is a nickel titanium tube/cannula.  For the Voyager Premium Irrigation Tips, the second tube/cannula is also stainless steel but undergoes an annealing process for improved flexibility.  Additionally, the second tube/cannula for certain Voyager Premium Irrigation Tips contains further processing to add side ports and close the end off by crimping or laser welding.  You state that the flexibility of the second tube/cannula is seen as an advantage to certain users based on their preferences.  Some dental professionals may prefer a second tube/cannula made of a polymer material whereas other dental professionals may prefer a second tube/cannula made of a metal material (stainless steel or nickel titanium). The Voyager Premium Irrigation Tips, Flexi-Glide Utility Tips, and NiTi SuperFlex Tips have silicone stoppers for marking root canal length.  The stoppers are optional and are added for user convenience to help mark root canal length; however, these stoppers are not required for marking root canal length. The tubes will be manufactured in the United States, Japan, South Korea, or India.  The first and second cannulas will be sourced independently in the United States, Japan, South Korea, or India, and will not necessarily be from the same country.  The plastic hubs, and stoppers if present, will be sourced in China.  Assembly of the finished dental tips will be performed in China.  The processing to produce the complete dental tips is described in your letter as follows: Manufacture of Cannula in United States, Japan, South Korea, or India: Processing of the cannulas consists of varying steps depending on the specifications.  The process begins with a flat strip of stainless-steel or NiTi that will be rolled and laser welded into the form of a tube.  The tube will be cold-worked through a die several times to toughen it and reduce its size down to the specified gauge dimensions, ranging from 16ga – 31ga.  Polymer cannulas may be formed by either extrusion or fused deposition.  An electric blade will cut the tubing to individual cannulas at specified lengths.  A grinding machine will create any specified features to the cannula end, including slotted/skive cuts or side ports.  Some cannulas, as in the case with side port tips, will undergo another step to close the end off by crimping or laser welding.  Next the cannula will undergo heat treatment for tempering or annealing to give the cannula its desired ductility, electropolishing to remove any burrs and give it luster, and citric acid passivation for rust prevention.  All of the aforementioned processing requires highly specialized machinery and skilled labor, and inspections are performed at each step. Assembly and Packing in China: To complete the assembly of a dental tip using the cannulas and hub, an automated assembly machine will be utilized.  The machine will be loaded with components and will automatically take the plastic hub, insert a cannula, apply an epoxy, cure the epoxy with flashes of ultraviolet radiation, and bend the first cannula.  The second cannula will then be inserted and bonded or crimped by hand at the end of the assembly line, along with addition of the optional silicone stopper (if present).  No processing will be performed to the cannulas or hubs at the facility other than this assembly.  After assembly, the tips will be packaged in multiple configurations to match SKUs specified by Vista Apex.  The tips will be packaged in cups, bags, or blister packs at various quantities.  These cups, bags, or packs are placed in corrugated boxes for shipping. The marking statute, section 304, Tariff Act of 1930, as amended (19 U.S.C. 1304), provides that, unless excepted, every article of foreign origin (or its container) imported into the U.S. shall be marked in a conspicuous place as legibly, indelibly and permanently as the nature of the article (or its container) will permit, in such a manner as to indicate to the ultimate purchaser in the U.S. the English name of the country of origin of the article. The "country of origin" is defined in 19 CFR 134.1(b) as "the country of manufacture, production, or growth of any article of foreign origin entering the United States. Further work or material added to an article in another country must effect a substantial transformation in order to render such other country the 'country of origin' within the meaning of this part." The test for determining whether a substantial transformation will occur is whether an article emerges from a process with a new name, character or use, different from that possessed by the article prior to processing.  See Texas Instruments Inc. v. United States, 69 C.C.P.A. 151 (1982).  However, if the manufacturing or combining process is merely a minor one that leaves the identity of the article intact, a substantial transformation has not occurred.  Uniroyal, Inc. v. United States, 3 CIT 220, 542 F. Supp. 1026, 1029 (1982), aff’d, 702 F.2d 1022 (Fed. Cir. 1983).  A substantial transformation determination is based on the totality of the evidence. See National Hand Tool Corp. v. United States, 16 C.I.T. 308 (1992), aff'd, 989 F.2d 1201 (Fed. Cir. 1993).  The issue of whether a substantial transformation occurs is determined on a case-by-case basis.  See HQ 561353, dated September 19, 2002.  In this case, the assembly and packaging performed in China are simple and minor processes.  Specifically, the assembly of the dental tips will be performed via a mechanically automated process that solely consists of adhering the components together with an epoxy solution and flashes of ultraviolet radiation and pre-bending the tip to a fixed angle.  The mechanized assembly of the components will be a highly repetitive, low-skill function that merely requires the assembly line be switched on, that the second tubes be inserted into the first tubes along with addition of the optional silicone stopper (if present), and that adhesive epoxy be used.  The additional processing of the dental tips will merely consist of packaging.  These processes do not change the name, character, and use of the pre-cut, pre-processed tubes.  You explain that these dental tips are pre-bent for the user’s convenience.  These dental tips could still perform their function without the bending, although the user would typically bend the tips for clinical use.  We find that no substantial transformation occurs in China.  You claim that the first cannula is the component that is critical in creating a functioning dental tip that allows the delivery of the dental materials.  The dental tips can still function as a tip to deliver various dental materials without the second tube/cannula.  The second cannula is an accessory that is used in conjunction with the first or primary tube/cannula, but it does not alter the basic functioning of the dental tip.  Based on the above, in our opinion, the essence of the dental tips is imparted by the first tubes/cannulas, which determine the origin of the products.  Accordingly, the country of origin of the dental tips will be the United States, Japan, South Korea, or India depending on the country of origin of the first tube/cannulas.  Please note whether an article may be marked with the phrase “Made in the USA” or similar words denoting U.S. origin, is an issue under the authority of the Federal Trade Commission (FTC).  We suggest that you contact the FTC directly. The holding set forth above applies only to the specific factual situation and merchandise description as identified in the ruling request.  This position is clearly set forth in Title 19, Code of Federal Regulations (CFR), Section 177.9(b)(1).  This section states that a ruling letter is issued on the assumption that all of the information furnished in the ruling letter, whether directly, by reference, or by implication, is accurate and complete in every material respect. In the event that the facts are modified in any way, or if the goods do not conform to these facts at time of importation, you should bring this to the attention of U.S. Customs and Border Protection (CBP) and submit a request for a new ruling in accordance with 19 CFR 177.2.  Additionally, we note that the material facts described in the foregoing ruling may be subject to periodic verification by CBP. This ruling is being issued under the provisions of Part 177 of the Customs and Border Protection Regulations (19 C.F.R. 177). A copy of the ruling or the control number indicated above should be provided with the entry documents filed at the time this merchandise is imported. If you have any questions regarding the ruling, please contact National Import Specialist Fei Chen at fei.chen@cbp.dhs.gov. Sincerely, Steven A. Mack Director National Commodity Specialist Division